SYNERGY™ XD H7493941816300Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 08714729980964), received between Nov 17, 2020 and Dec 23, 2025 — classified as 1 death, 15 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (18 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT SEAL WAS COMPROMISED. A 3.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE STENT WAS OPEN IN THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23885144 ↗
• MalfunctionDec 4, 2025Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 3.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT FAILED TO CROSS THE LESION AND BECAME DISLODGED FROM THE BALLOON INTO THE LEFT MAIN, WHERE IT HAD TO BE IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND NO FURTHER EVENT DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716957 ↗
• InjuryDec 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGE OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A NON-BSC GUIDE CATHETER WAS INSERTED. PRIOR TO BALLOON INFLATION, A 3.00 X 16MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION, HOWEVER; THE STENT CAME OFF THE BALLOON AND COULD NOT BE REMOVED. NO PRESSURE HAD BEEN APPLIED TO THE BALLOON BEFORE THE STENT DETACHED. AN ATTEMPT WAS MADE TO SNARE THE STENT, BUT THIS WAS UNSUCCESSFUL, AND THE STENT WAS ULTIMATELY DEPLOYED INTO THE LEFT MAIN CORONARY ARTERY. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT FULLY RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23696912 ↗
• MalfunctionOct 30, 2025Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS VESSEL. A 3.00 X 16MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS SELECTED FOR TREATMENT. THE STENT WAS ADVANCED, BUT FAILED TO REACH THE LESION SITE. DURING RETRACTION BACK THROUGH A GUIDE EXTENSION CATHETER, THE STENT REPORTEDLY DETACHED FROM THE DELIVERY SYSTEM BALLOON. THE DISLODGED STENT REMAINED WITHIN THE GUIDE EXTENSION CATHETER AND WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING ANOTHER STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425682 ↗
• MalfunctionAug 15, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. THE MORE THAN 70% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TO SEVERELY TORTUOUS AND NON-CALCIFIED CORONARY ARTERY. A 3.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. BALLOON INFLATION WAS PERFORMED USING A NON-BOSTON SCIENTIFIC INFLATION DEVICE, WITH A 50/50 SALINE-CONTRAST MIXTURE. AFTER STENT DEPLOYMENT, THE STENT BALLOON FAILED TO DEFLATE, DESPITE MULTIPLE ATTEMPTS TO PULL NEGATIVE PRESSURE. THE PHYSICIAN HAD TO REMOVE THE STENT DELIVERY SYSTEM, GUIDEWIRE, GUIDE EXTENDER, AND GUIDE CATHETER AS A SINGLE UNIT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816646 ↗
• MalfunctionJul 22, 2025Contamination; Contamination

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 3.00 X 16 MM SYNERGY XD STENT WAS SELECTED FOR USE. HOWEVER, UPON OPENING THE STENT PACKAGING AND REMOVING THE DEVICE FROM THE HOOP, A PIECE OF PLASTIC WAS OBSERVED FALLING FROM THE HOOP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22565015 ↗
• MalfunctionJul 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, PART OF THE DEVICE DETACHMENT OCCURRED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22484173 ↗
• MalfunctionApr 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 3.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, THE STENT WAS FOUND TO BE DAMAGED UPON REMOVAL FROM THE PACKAGE AND THE STENT STRUTS HAD SEPARATED FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21785403 ↗
• InjuryOct 21, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT INSIDE THE PATIENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASES AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. HOWEVER, WHILE REMOVING THE STENT DELIVERY CATHETER OUT OF THE BODY, THE STENT DISLODGED IN THE LEFT MAIN WITHOUT THE INVOLVEMENT OF INFLATION DEVICE. A SNARE WAS THEN USED TO RETRIEVE THE STENT COMPLETELY, AND A NON-BOSTON SCIENTIFIC DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20495643 ↗
• MalfunctionSep 24, 2024Contamination; Contamination

  IT WAS REPORTED THAT DEVICE CONTAMINATION MIGHT OCCURRED. DURING PREPARATION, A 3.00 X 16MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS SELECTED FOR USED; AND IT WAS NOTICED THAT THE DESICCANT FILTER OF THE STERILE PACKAGING WAS TORN OPEN. A NEW SYNERGY XD DES WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292656 ↗
• MalfunctionSep 9, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION, 80% STENOSED, WAS LOCATED IN A MODERATELY TORTUOUS AND CALCIFIED CORONARY ARTERY. THE COMPLIANT BALLOON WAS INFLATED IN AN ATTEMPT TO DEPLOY A 3.00 X 16MM SYNERGY XD STENT. HOWEVER, THE SHAFT BROKE WHILE CROSSING THE LESION. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169604 ↗
• MalfunctionMay 28, 2024Difficult to Advance; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT MOVED ON BALLOON OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A COMET WIRE WAS INTRODUCED FOR DFR OF THE LAD. FOLLOWING PRE-DILATION WITH A 2.5MM EMERGE BALLOON, THE 3.00 X 16 MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED OVER THE COMET WIRE. THE DEVICE WAS DIFFICULT TO ADVANCE AND WHEN IT WAS BEING REMOVED, THE STENT STARTED TO COME OFF THE BALLOON. EVERYTHING WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NEW WIRE AND STENT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19411445 ↗
• DeathMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. THE TARGET LESIONS WERE LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND LEFT CIRCUMFLEX (LCX) ARTERY. SIX SYNERGY XD DRUG ELUTING STENTS WERE IMPLANTED, A 2.25MM X 12MM, A 2.75MM X 12MM, A 3.00 X 16MM, A 3.00MM X 38MM, A 3.5MM X 28MM AND A 3.5MM X 48MM, WITH NO VISIBLE EDGE DISSECTIONS. TWENTY MINUTES AFTER ARRIVING IN THE RECOVERY UNIT, THE PATIENT COMPLAINED ABOUT CHEST PAIN AND DEVELOPED ST SEGMENT ELEVATION. THE PATIENT WAS BROUGHT BACK TO THE CARDIAC CATHETERIZATION LABORATORY AND THE STENTS IN BOTH THE LAD AND LCX WERE THROMBOSED. THROMBECTOMY WAS PERFORMED IN AN ATTEMPT TO RE-OPEN THE ARTERIES. THE PATIENT CODED FOR SIXTY MINUTES AND EXPIRED.

  Patient problems: Cardiac Arrest; Chest Pain; Non specific EKG/ECG Changes; Thrombosis/Thrombus

  MAUDE report 19368005 ↗
• InjuryMay 6, 2024Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED PROXIMAL TO MID RIGHT CORONARY ARTERY (RCA). FOLLOWING PRE-DILATION WITH A 2.50 COMPLIANT BALLOON, THE 3.00 X 16 MM SYNERGY XD STENT WAS INTRODUCED. RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING TO PASS THE STENT ACROSS THE LESION AND WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE STENT HAD COME OFF THE BALLOON JUST BEFORE THE GUIDE CATHETER. THE DISLODGED STENT WAS PARTIALLY IN THE AORTA, SO THE GUIDE CATHETER WAS USED TO PUSH THE STENT OUT OF THE AORTA AND INTO THE RCA OSTIUM. STENT DEFORMATION WAS THEN NOTED. NO ATTEMPT WAS MADE TO SNARE THE STENT AND A BALLOON WAS NOT ABLE TO BE PLACED TO EXPAND THE STENT. THE PATIENT NEEDED AORTIC VALVE REPLACEMENT, SO THE PHYSICIAN CALLED SURGERY TO BYPASS THE RCA AND REPLACE THE VALVE AT THE SAME TIME. FOLLOWING OPEN HEART SURGERY, THE PATIENT FULLY RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19248586 ↗
• InjuryJan 11, 2024Positioning Failure; Positioning Problem; Positioning Failure; Positioning Problem

  IT WAS REPORTED THAT STENT PLACEMENT FAILED AND THE PATIENT EXPERIENCED PAIN. TWO SYNERGY XD WERE ADVANCED FOR TREATMENT, BUT FAILED TO "HOOK" AND HAD TO BE PULLED OUT. PER THE PATIENT, INADEQUATE SEDATION WAS PROVIDED AND EXCRUCIATING PAIN DURING REMOVAL OF THE STENTS WAS EXPERIENCED. A THIRD SYNERGY XD WAS SUCCESSFULLY PLACED TO COMPLETE THE PROCEDURE.

  Patient problems: Pain

  MAUDE report 18499295 ↗
• InjuryNov 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ARTERY. A 3.00 X 16 MM SYNERGY XD WAS ADVANCED AND CAME OFF OF THE DELIVERY SYSTEM PROXIMAL TO THE LESION SITE. THE DEVICE WAS CRUSHED AGAINST THE VESSEL WALL IN THE OBTUSE MARGINAL USING ANOTHER BALLOON. THE PROCEDURE WAS COMPLETED WITH AN ADDITIONAL STENT WITHOUT FURTHER COMPLICATIONS. THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211814 ↗
• MalfunctionOct 25, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING UNPACKING OF A 3.00 X 16MM SYNERGY XD DRUG-ELUTING STENT, IT WAS NOTED THAT THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18006708 ↗
• MalfunctionJul 14, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED OSTIAL VESSEL. A 3.00 X 16MM SYNERGY XD DRUG ELUTING STENT WAS IMPLANTED FOR TREATMENT. HOWEVER, DURING REMOVAL OF THE DEVICE, THE ROD SEPARATED FROM THE BALLOON PORTION IN THE GUIDE CATHETER. THE STENT DELIVERY SYSTEM (SDS) BROKE AT 121 CM FROM THE HUB. THE DEVICE WAS REMOVED AS A WHOLE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED, AND THE PATIENT CONDITION WAS FINE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17324594 ↗
• MalfunctionMay 11, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED MIDDLE TO DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER A NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE AND EXTRA SUPPORT WIRE CROSSED THE LESION, PRE-DILATATION WAS PERFORMED WITH 3.0 X 20 NC BALLOON CATHETER, AND A NON-BSC GUIDE EXTENSION WAS THEN LOOP ACROSS THE LESION. SUBSEQUENTLY, A NC BALLOON CATHETER WAS THEN REMOVED, AND A 3.00 X 16MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE WHILE THE STENT WAS STILL IN THE NON-BSC GUIDE EXTENSION THE SHAFT WAS BENT AND BROKE 10 INCHES FROM THE HUB DUE TO FRICTION AND TORTUOSITY. THE DEVICE WAS REMOVED FROM INSIDE PATIENT INTACT BY PULLING IT OUT BY THE HAND. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16915174 ↗
• InjuryJan 9, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 3.00 X 16MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE SHAFT WAS FRACTURED DURING REMOVAL LEAVING THE SDS BALLOON IN THE PATIENT. THE DEVICE WAS RETRIEVED BY SNARING USING ANOTHER BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16126554 ↗
• MalfunctionNov 18, 2022Entrapment of Device; Difficult to Advance; Material Deformation; Entrapment of Device; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 3.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS LOADED ON A NON-BOSTON SCIENTIFIC GUIDEWIRE BUT FAILED TO TRACK AND ENDED UP GETTING FUSED TO THE GUIDEWIRE OUTSIDE OF THE BODY. AFTER AN UNSUCCESSFUL ATTEMPT TO FORCEFULLY REMOVE THE DEVICE FROM THE GUIDEWIRE, THE PHYSICIAN NEEDED TO CUT THE GUIDEWIRE TO GET THE DEVICE OFF. IT WAS ALSO NOTED THAT THE STENT BECAME DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15824618 ↗
• MalfunctionNov 15, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. FOLLOWING PRE-DILATATION WITH A 2.0X15 EMERGE BALLOON CATHETER, A 3.00 X 16MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION AND IT WAS NOTED THAT THE SHAFT BROKE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15801077 ↗
• MalfunctionNov 8, 2022Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE DEVICE WAS CONTAMINATED. A 3.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING PREPARATION, THE DEVICE DROPPED DUE TO DIFFICULTY REMOVING FROM THE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15751632 ↗
• InjuryNov 7, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. A 3.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE THE DEVICE FAILED TO CROSS THE LESION AND VESSEL DISSECTION AT THE DISTAL STENT EDGE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A 3.00 X 12MM NON-BOSTON SCIENTIFIC STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 15744414 ↗
• MalfunctionSep 28, 2022Break; Break

  IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED. A 3.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION OF THE DEVICE THE SHAFT FRACTURED OUTSIDE THE PATIENT. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15496069 ↗